Peer-Based Intervention for Genetic Evaluation for Prostate Cancer Among African American Men: The Peer Genetic Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 149
- 试验地点
- 1
- 主要终点
- Change in of decisional conflict
研究概览
简要总结
This trial studies how well a peer-based health education program works in reducing barriers and changing attitudes and beliefs of prostate cancer genetic screening in African American participants with or without a previous personal or family history of prostate cancer. Participating in a peer-based health educational program may help participants learn more about prostate cancer and how their personal or family history of disease may increase their risk of prostate cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 69 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Able to read and speak English comfortably
- •With or without a personal or family history of PCA
- •Do not need to be an established patient at CityLife Neighborhood Clinic in order to participate
排除标准
- •Do not read or speak English comfortably
- •Men who participated in a focus group will be excluded from participating in the intervention
研究组 & 干预措施
Arm I (health education)
Participants attend 1-2 monthly peer educator-led education sessions about PCA genetic testing over 3 hours each for 18 months.
干预措施: Questionnaire Administration (Other)
Arm I (health education)
Participants attend 1-2 monthly peer educator-led education sessions about PCA genetic testing over 3 hours each for 18 months.
干预措施: Educational Intervention (Other)
Arm II (cancer educational materials)
Participants receive mailed informational materials about PCA risk, family history, and genetic testing.
干预措施: Cancer Educational Materials (Behavioral)
Arm II (cancer educational materials)
Participants receive mailed informational materials about PCA risk, family history, and genetic testing.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Change in of decisional conflict
时间窗: Baseline up to 2 months
Will be assessed by the 4-item Sure of myself; Understand information; Risk-benefit ratio; Encouragement (SURE) scale. To compute a summary decisional conflict score, the Likert-scaled responses will be averaged across the SURE item responses provided by a subject completing at least 2 of the 4 questions. The change in decisional conflict scores between baseline and endpoint at 2-months will be calculated and group means for these changes compared between subjects randomized to receive control materials vs. those randomized to receive the peer health education intervention (i.e., by intention to treat). The significance of the difference will be evaluated at the 0.05 level using a two-sided Student's t-test. The assumptions for this test will be carefully evaluated. If the changes are substantially skewed, they will be summarized with group medians and evaluated for significant differences by the nonparametric Wilcoxon's rank sum test.
Awareness of risks and benefits of genetic testing
时间窗: Up to 2 months post study
Will be summarized in tables with descriptive statistics or graphically in data plots at each time they are assessed along with changes in responses over time. Will investigate imbalances in these data for potential confounding of primary and exploratory endpoint analyses and investigate disparities and intervention effect modification in various subgroups of subjects.
Perceptions of genetic testing
时间窗: Up to 2 months post study
Will be summarized in tables with descriptive statistics or graphically in data plots at each time they are assessed along with changes in responses over time.
Genetic testing
时间窗: Up to 2 months post study
Will be summarized in tables with descriptive statistics or graphically in data plots at each time they are assessed along with changes in responses over time.
Prostate Cancer response
时间窗: Up to 2 months post study
Will be summarized in tables with descriptive statistics or graphically in data plots at each time they are assessed along with changes in responses over time.
次要结局
未报告次要终点